The present disclosure relates to a method for authenticating an instrument for processing a biological sample or reagent and a system comprising an instrument for processing a biological sample or reagent.
In vitro diagnostic testing has a major effect on clinical decisions, providing physicians with pivotal information. Particularly, there is great emphasis on providing quick and accurate test results in critical care settings. In vitro diagnostic testing is usually performed using instruments operable to execute one or more processing steps/workflow steps on one or more biological samples and/or one or more reagents, such as pre-analytical instruments, post-analytical instruments and also analytical instruments.
Analytical instruments/analyzers are configured to obtain a measurement value. An analyzer is operable to determine via various chemical, biological, physical, optical or other technical procedures a parameter value of the sample or a component thereof. An analyzer may be operable to measure the parameter of the sample or of at least one analyte and return the obtained measurement value. The list of possible analysis results returned by the analyzer comprises, without limitation, concentrations of the analyte in the sample, a digital (yes or no) result indicating the existence of the analyte in the sample (corresponding to a concentration above the detection level), optical parameters, DNA or RNA sequences, data obtained from mass spectroscopy of proteins or metabolites and physical or chemical parameters of various types.
An analytical instrument may comprise units assisting with the pipetting, dosing, and mixing of samples and/or reagents. The analyzer may comprise a reagent holding unit for holding reagents to perform the assays. Reagents may be arranged for example in the form of containers or cassettes containing individual reagents or group of reagents, placed in appropriate receptacles or positions within a storage compartment or conveyor. It may comprise a consumable feeding unit.
The analyzer may comprise a process and detection system whose workflow is optimized for certain types of analysis. Examples of such analyzer are clinical chemistry analyzers, coagulation chemistry analyzers, immunochemistry analyzers, urine analyzers, nucleic acid analyzers, used to detect the result of chemical or biological reactions or to monitor the progress of chemical or biological reactions.
Such instruments need to be registered to build up a trust relationship to electronic devices for safe communication purposes therewith. For example, such instruments need to be registered to build up a trust relationship to remote electronic devices from the manufacturer of the instruments in order to properly operate. Such remote electronic devices are devices which are spatially separated from the instrument. The instrument and the remote electronic device may communicate with each other such as by a wireless LAN connection. The trust relationship may also be built up to other local electronic devices, e.g., data management systems of laboratory automation systems on the same LAN connection. For this purpose, current instruments provide for a user to enter a Personal Identification Number (PIN) on the device. However, a significant number of instruments do not have a possibility such as a keyboard to enter numbers and/or characters.
Therefore, there is a need for a possibility to build up a trust relationship to an electronic device, particularly to a remote electronic device from a manufacturer of the instrument, independent on whether the instrument provides a device for entering numbers and/or characters.